Effect of antiseptic and antibiotic usage within the implant on the pro-inflammatory cytokines interleukin 1β and interleukin 6 in gingival crevicular fluid for the contact of the implant and abutment
Control of inflammation around dental implants in order to reduce the amount of bone erosion around the implant neck, the health of surrounding soft tissues and increase the efficiency of dental implant
Design
Clinical trial with 24 samples in 3 groups
Settings and conduct
Each of the materials examined at an uncovering session is placed inside the implant bolt and the healing screw is closed. Then, in three sessions of Prosthesis Delivery Molding and one month after the delivery of the prosthesis, samples are taken from the patients. Each area is isolated by cotton roll and is airborne for 5 seconds to dry out any salivary contamination from the area. These paper points are inserted into four distinct regions (mesiobuccal, distobuccal, mesiolingual and distolingual) into the gingival groin and held for 30 seconds. Any tissue that looks at the blood contamination will be discarded. Then, immediately any paper clip inside the small sterile tubes containing the buffer fluid and then placed at -80 ° C until all samples are freeze. Samples will be sent to the Immunology Laboratory to measure the pre-inflammatory cytokinesis IL6 and IL1β by the ELISA kit.
Participants/Inclusion and exclusion criteria
Criteria for entering:
Have at least 3 implants in one jaw
Having at least 18 years of age
The probe depth around the implant between 1-3 mm
Criteria for exiting:
People have been scaling in the last three months in the last three months
Pregnant and lactating women
Patients receiving antibiotics in the last 6 months
Having any systemic disease, such as diabetes, that affects oral health
Intervention groups
Intervention group: The study is split mouth and each patient will have 3 different environments chlorohexidine 2%, tetracycline 3% and dry environments in each implant.
Main outcome variables
inflammationInflammation of the implant and abutment contact point
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190525043702N1
Registration date:2019-06-05, 1398/03/15
Registration timing:registered_while_recruiting
Last update:2019-06-05, 1398/03/15
Update count:0
Registration date
2019-06-05, 1398/03/15
Registrant information
Name
Ramin negahdari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
ramin_n_dds@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of antiseptic and antibiotic usage within the implant on the pro-inflammatory cytokines interleukin 1β and interleukin 6 in gingival crevicular fluid for the contact of the implant and abutment
Public title
Effect of antiseptic and antibiotic usage within the implant in gingival crevicular fluid for the contact of the implant and abutment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least 3 implants in one jaw
Having at least 18 years of age
The probe depth around the implant between 1-3 mm
Exclusion criteria:
People have been scaling in the last three months in the last three months
Pregnant and lactating women
Patients receiving antibiotics in the last 6 months
Having any systemic disease, such as diabetes, that affects oral health
Drug addiction, cigarette or alcohol
History of the use of bisphosphonates
History of the use of bisphosphonates
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Tabriz University of Medical Sciences, Daneshgah St.
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2019-05-21, 1398/02/31
Ethics committee reference number
IR.TBZMED.REC.1398.166
Health conditions studied
1
Description of health condition studied
Implantytis
ICD-10 code
T85.9
ICD-10 code description
Unspecified complication of internal prosthetic device, implant and graft
Primary outcomes
1
Description
Interleukin 1β
Timepoint
1 month
Method of measurement
Elisa kit
2
Description
Interleukin 6
Timepoint
1 month
Method of measurement
Elisa kit
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: The study is split mouth and each patient will have chlorohexidine 2% in first implant.
Category
Diagnosis
2
Description
Second Intervention group: The study is split mouth and each patient will have tetracycline 3% in second implant.
Category
Diagnosis
3
Description
Third Intervention group: The study is split mouth and each patient will have Saliva in third implant.
Category
Diagnosis
4
Description
Control group: The study is split mouth and each patient will have dry environments in control implant.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Dental Faculty, Dental Prosthodontics Department
Full name of responsible person
Dr. Ramin Negahdari
Street address
Golgasht Street,Tabriz Dental Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5619941213
Phone
+98 41 3335 5969
Email
ramin_n_dds@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reza Pourabbas
Street address
Tabriz Dental Faculty, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Email
ramin_n_dds@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ramin Negahdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Dental Faculty, Golgasht Street Tabriz East Azarbaijan , Islamic Republic Of Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
Email
ramin_n_dds@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ramin Negahdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Dental Faculty, Golgasht Street Tabriz East Azarbaijan , Islamic Republic Of Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
Email
ramin_n_dds@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ramin Negahdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Dental Faculty, Golgasht Street Tabriz East Azarbaijan , Islamic Republic Of Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
Email
ramin_n_dds@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data has subscription capability
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
All people
Under which criteria data/document could be used
No specific case
From where data/document is obtainable
Email Dr. Negahdari
What processes are involved for a request to access data/document